COSMETIC VS. DRUG

A skincare product is considered a cosmetic or a drug, depending on its intended use. The U.S. Food and Drug Administration (FDA) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied...for cleansing, beautifying, promoting attractiveness, or altering the appearance." By law, cosmetics cannot claim to alter the structure or function of the skin.

Moisturizing is a cosmetic claim. A moisturizer that claims to decrease the "appearance" of fine lines and wrinkles by increasing the water content of skin is considered a cosmetic. Although skincare product manufacturers must follow the laws and regulations that apply to cosmetics, cosmetics do NOT require FDA approval before going to market. Skincare products must not be misbranded or adulterated but they do not need to PROVE efficacy or safety. They are recognized by the FDA as having no medical value.

Products that intend to change the structure or function of skin are considered drugs. The FDA defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles...intended to affect the structure or function of..." skin. If a product claims to alter the skin's structure or function, for example, by actually "removing" wrinkles or increasing the skin's production of collagen, it is considered a drug. As a drug, the product must get FDA approval before going to market. In addition, the manufacturer must prove the product's safety and efficacy.

Manufacturers of over-the-counter (OTC) skincare moisturizers, including "eye" creams, "night" creams, "firming" creams, "toning" creams, "anti-aging" creams, "anti-wrinkle" creams, or rejuvenating serums, cannot claim that their product will change the structure of the skin itself. The product may claim to change the "appearance" of fine lines and wrinkles (by increasing the water content of the skin), but, by law, cannot claim to change the actual structure or function of the skin.